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FDA 510(k)

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

K-Number: K182138 · 2018-09-05

ApplicantEleckta Limited
Decision Date2018-09-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is the device name listed in this FDA 510(k) record. The listed applicant is Eleckta Limited. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K182138. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Eleckta Limited. The 510(k) number is K182138.

When did Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD receive FDA 510(k) clearance?

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD received FDA 510(k) clearance on 2018-09-05, under 510(k) number K182138.

Who is the listed applicant for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

The FDA 510(k) record lists Eleckta Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD?

The FDA product code for Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD is IYE.

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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